Active Ingredient
Sodium Monofluorophosphate 0.76% w/w (0.15% w/v fluoride ion)..................................Purpose: Anticavity
Kroger Company
FDA Label NDC 30142-621
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Kroger Company (NDC 30142-621). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
aids in the prevention of dental caviites
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Directions
Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.
Other Information
Store in a cool dry place. Keep tube capped when not in use.
Inactive Ingredients
glycerin, dicalcium phosphate, PEG-12, PVP, PEG/PPG 116/66 copolymer, hydrated silica, hydrogen peroxide, propylene glycol, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water
Dosage & Administration
Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.
Package Label.Principal Display Panel
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Carton Label (Mm1)
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Tube Label (Mm2)
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